NMPA (CFDA) Updates

December 6, 2019

Record number of Guidelines and Standards announced by NMPA in November

NMPA published unprecedented number of medical device regulations in November, including 21 final guidelines, 14 draft guidelines for feedback and 19 final industry standards. Generic Guidelines Among those are three […]
November 26, 2019

NMPA New Guideline on How to Address “Submission Deficiency” in China

NMPA issued the “Medical Device Submission Document Requirements during the Supplement Phase” (Draft) on November 11, 2019. Feedback needs to be summited by November 30, 2019. The document specifies the […]
November 13, 2019

NMPA (CFDA) News Roundup 201910

The NMPA (CFDA) News Roundup covers government announcements, policies, standards, guidelines, QA/recall/AE, and new approvals in medical devices and IVDs in China. It is edited by China Med Device, LLC […]
November 11, 2019

AdvaMed Webinar: Latest Developments in Clinical Pathways for NMPA (CFDA) Submission

Time: Tuesday, November 12, 2019 | 11:00 am – 12:00 pm ET Presented by China Med Device, LLC Register Here This webinar will cover different clinical pathways and how to […]
November 6, 2019
NMPA Regulations

China Medical Device Regulations – An Overview

China National Medical Products Administration regulates medical devices and pharmaceutical products across China. The NMPA was also known as China Food and Drug Administration in the past. For medical device […]